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Study of Monoclonal Antibody Nirsevimab Against Respiratory Syncytial Virus (RSV) in Participants up to 24 Months of Age in India

StatusActive, Not Recruiting
PhasePhase 4
SponsorSanofi
Started2025-07-31
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 23, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
The purpose of this study is to describe the safety and efficacy outcomes associated with the use of nirsevimab, administered as per routine clinical practice, in neonates and infants aged 0 to 12 months born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Amendment record

Amended 5 times since 2025-07-31; most recent filed 2026-03-19. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2026-03-19
Amendment Recruiting→Active, Not Recruiting Study Status, Study Design, Eligibility, Contacts/Locations v5
2025-12-11
Amendment Study Status, Contacts/Locations v4
2025-11-13
Amendment Study Status, Contacts/Locations v3
2025-09-26
Amendment Study Status, Contacts/Locations v2
2025-08-14
Amendment Study Status v1
2025-07-31
Original filing
Trial Details
NCT Number NCT07109297
Lead Sponsor Sanofi
Conditions RSV Immunization
Enrollment 110 participants
Start Date 2025-07-31
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-23